California Governor Newsom Paves the Way for Psychedelic Medicine
LOS ANGELES- In a historic move, Governor Gavin Newsom has put California at the forefront of the psychedelic medicine movement. The Democratic Governor recently signed groundbreaking legislation that would allow healthcare professionals to prescribe substances like MDMA and psilocybin, currently prohibited under federal law, once they are federally decriminalized.
This state legislation, a potential game-changer in the world of psychedelic therapies, stipulates that as soon as any drug presently classified under Schedule I of the Controlled Substances Act is reclassified by the federal government, healthcare professionals in California will be permitted to prescribe and distribute these drugs. This is particularly impactful for psilocybin and MDMA, both of which have garnered “breakthrough therapy” designations from the U.S. Food and Drug Administration (FDA). The clinical trials for these substances, in terms of medicinal applications, are in advanced stages.
The catalyst for this decision aligns with the recent release of Phase 3 data on MDMA-assisted therapy by MAPS Public Benefit Corporation. This study highlighted the notable efficacy of the therapy in comparison to a placebo. Remarkably, 86.5% of the participants in the MDMA-assisted therapy group reported a significant improvement in their condition after 18 weeks. In the placebo group, the figure stood at 69%. Moreover, by the end of the study, 71.2% of individuals who underwent MDMA-assisted therapy no longer qualified for a PTSD diagnosis according to DSM-5 standards, compared to just 47.6% in the placebo group.
Beyond this bill, Governor Newsom is also considering several other legislative pieces related to psychedelics, including a bill aimed at decriminalizing the possession of psychedelics. Whether he will sign them remains to be seen.
Adapting California’s Controlled Substance Framework
The existing law in California, known as the California Uniform Controlled Substances Act, segregates controlled substances into five schedules. Schedule I encompasses the substances with the highest restrictions. Violations associated with these substances are typically classified as criminal offenses, with some specific exemptions.
The new bill, should the federal law change regarding controlled substances, intends to grant healthcare professionals, such as doctors and pharmacists, the authority to prescribe, distribute, or dispense products containing these substances, strictly in alignment with federal guidelines.
Furthermore, the bill clarifies that, upon the enactment of the pertinent federal changes, the use and distribution of these products, when in compliance with federal law, will be deemed medically valid and sanctioned under state law.